Identity
- Trade Name
- Simplify FDA UDI
- Generic Name
- Orthopaedic implantation hammering attachment FDA UDI
- Device Name
- Simplify Slide Hammer FDA UDI
- Model / Reference
- 76242 FDA UDI
- Description
- Simplify Slide Hammer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843285100894 FDA UDI
- PMA Number
- P200022 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- Orthopaedic implantation hammering attachment FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implantation hammering attachment
Simplify by Nuvasive, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implantation hammering attachment.
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- X-PAC — Expanding Innovations, Inc. · Class I
- EXTRACTOR — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
- IMPACTOR PAD — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Cleared under the same submission
P200022 also covers:
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
- Simplify — Nuvasive, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Nuvasive, Inc.
Sources (1)
- FDA UDI 8a656f44-3386-4cc3-8179-d786028930c6 35 fields · synced Jun 6, 2026